Sr. Manager Commercial Quality

Overall purpose of job:

该角色负责强生创新制药上市产品和/或由中国强生创新制药商业质量团队负责的J&J公司产品的质量，并满足适用要求和质量体系维护。

This role is responsible for the quality of, and meeting the applicable requirements for, the products that J&J Innovative Medicine markets and/or the products under J&J company which take responsibility by China J&J Innovative Medicine CQ team and quality system maintenance.

他/她还负责确保遵守当地法律/法规以及适用于强生创新制药中国承诺的GxP活动的强生质量政策要素。在此岗位上，他/她已明确了确保质量体系和过程（如质量手册中所述）得到实施、维护并致力于持续改进的权力和责任。

He/she is also taking responsible to ensure compliance with the local laws/regulations and the elements of the Johnson & Johnson Quality Policy that are applicable to the GxP activities J&J Innovative Medicine undertakes. In this role he/she has defined authority and responsibility for ensuring that quality system and processes, as are described in the Quality Manual (QM), are implemented, maintained and is dedicated to continuous improvement thereof.

该职位作为强生制药有限公司GSP质量负责人，全面负责GSP药品质量管理工作，对药品质量管理有否决权。

As the GSP quality head of Johnson & Johnson Pharmaceutical Co., Ltd., this position is fully responsible for GSP drug quality management and has the decision power for drug quality management under the GSP.

Essential duties and responsibilities:

·       全面负责产品质量管理工作，独立履行职责，在公司内部对产品质量管理具有裁决权

Fully responsible for product quality management, perform duties independently, make decision for product quality management

·       组织建立和完善公司经营质量管理体现，对该体系进行监控，确保其有效运行。

Organize the establishment and improvement of the company's business quality management system, monitor the system and ensure its effective operation

·       通过符合相应要求（法律、法规和强生质量政策、标准和程序的要素等）来建立和维护质量体系。

Establishing and maintaining Quality System via transposition of the applicable requirements (laws, regulations and the elements of the J&J quality policy, standards and procedures etc.).

·       确保通过质量手册中的现有流程适当实施和跟进遵守新监管标准所需的措施。

Ensure the appropriate implementation and follow-up of actions needed to comply with new regulatory standards through existing processes in quality manual.

·       定期对公司经营质量管理体系进行监督检查，检查结果直接上报所在地食品药品监督部门。

Conduct regular supervision and inspection of the company's business quality management system, and report the inspection results directly to HA

·       定期在质量管理体系关键要素发生重大变化时，组织开展内审。

Organize internal audits on a regular basis when key elements of the quality management system change significantly

·       对公司购进、储存、销售、运输过程中涉及的可能影响产品质量等问题行使决定权。

Make decision on the company's purchase, storage, sales, transportation and other issues that may affect product quality.

·       对公司的购销资质证明文件、产品标签说明书、合同、票据、汇款单位、产品来源及真伪等进行审查和甄别。

Review and identify the purchase and sales qualification documents, product label instructions, contracts, bills, remittance units, product sources and authenticity, etc

·       审核质量管理程序，组织对各项质量管理程序执行情况的检查与考核。

Audit quality management procedures, conduct inspection and assessment of the implementation of quality management procedures

·       负责对首营企业和首营品种的质量审批。

Quality approval for first sale enterprise and first sale product

·       研究和确定公司质量管理工作的重大问题。

Research and identify major issues of quality management。

·       负责对计算机系统权限的审批。

Approval of computer system permissions

·       负责验证工作的监督、指导、协调与审批。

Responsible for the supervision, guidance, coordination and approval of validation work

·       根据质量手册中概述的上报程序，通知LOC商业质量负责人和其他受影响利益相关者有关产品质量、安全性和/或IT合规性的任何实质性问题。

Notify and engage LOC Head of Commercial Quality and other affected stakeholders with any substantive concerns regarding product quality, safety and/or IT compliance, as per the Escalation procedures outlined in Quality Manual.

·       根据统计数据分析，向经理和其他利益相关者提供质量洞察力。

Provide quality insight to manager and other stakeholders according to statistics data analysis.

·       领导并上报关键产品问题，并及时支持召回/现场行动。

Lead and escalate critical product issue and support the recall/field actions in timely manner.

·       质量负责人指定的其他工作。

Other works assign by Head of Quality.